NCT05525338 - Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels | Biotech Hunter

Enrollment

196

Participants

Timeline

Start Date

March 23, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions

Drug MonitoringCarcinoma, Non-Small-Cell LungLung CancerAnaplastic Lymphoma Kinase Gene MutationAnaplastic Lymphoma Kinase Gene Translocation

Interventions

DRUG

Alectinib

In case of an alectinib plasmaconcentration Cmin \<435 ng/mL, determined by TDM, and manageable toxicity, the alectinib dose will be increased with 150mg BID up to a maximum of 900mg BID. In case of unacceptable toxicity (i.e. unbearable or persistent grade 2 toxicity and grade 3/4 toxicity), the alectinib dose can be reduced by 150mg BID.

Trial Locations (8)

94805

NOT_YET_RECRUITING

Gustave Roussy, Villejuif

6525 GA

RECRUITING

Radboud University Medical Center, Nijmegen

6229 HX

RECRUITING

Maastricht University Medical Center +, Maastricht

1066 CX

RECRUITING

The Netherlands Cancer Institute, Amsterdam

1105 AZ

RECRUITING

Amsterdam University Medical Center, Amsterdam

2333 ZA

RECRUITING

Leiden University Medical Center, Leiden

3015 GD

RECRUITING

Erasmus Medical Center, Rotterdam

9713GZ

RECRUITING

University Medical Center Groningen, Groningen